Recalls / Class II
Class IID-762-2014
Product
Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE C.V., Mexico.
- Affected lot / code info
- Lot #: a) 10119730, Exp 9/30/2013; b) 10115568, 10115570, Exp 6/30/2013; 10119728, Exp 9/30/2013.
Why it was recalled
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Recalling firm
- Firm
- Novartis Consumer Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10401 Hwy 6, Lincoln, Nebraska 68517-9626
Distribution
- Distribution pattern
- Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Timeline
- Recall initiated
- 2013-06-18
- FDA classified
- 2014-01-17
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-762-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.